MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DLF181650

Device Problems Difficult To Position (1467); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.(b)(4).(b)(6).Conclusion: the deltafill 18 products were not returned for investigation.A review of manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection processes related to the reported complaint.The events of resistance between the deltafill18 coils and the microcatheters as well as the positioning difficulty and unravelling of one of the coils in the microcatheter could not be confirmed without product return.The root cause of the events could not be determined; however, the unravelling of the coil may have been associated with repeated insertion and withdrawal of the coil in the microcatheter may have contributed to the unravelling.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.

Event Description

As reported by a healthcare professional, during coil embolization of a renal artery aneurysm, a deltafill18 (dlf181855/ s13264) was inserted into the carry leon microcatheter, and some resistance felt at the middle part of the microcatheter.The physician attempted to insert it with some force, and the delivery wire came off from the sheath introducer and was exposed.Therefore, it was replaced with another deltafill18 (dlf181855/ lot s13264).However, there was some resistance felt with the microcatheter and the delivery wire came off from the sheath introducer and exposed again.Then, the micro catheter was replaced with the prowler select plus (606s255fx/lot unk) and the procedure continued.A coil (16mm deltafill) was implanted without any issue, and the deltafill18 (dlf181650/ lot s13345) was inserted into the microcatheter; however, there was resistance felt and it was removed from the patient.After removal, it was handled to see if the microcoil could function and the wire came off from the sheath introducer and exposed the dpu/coil.It was replaced with another deltafill18 (dlf181650/ lot s13345), but it got stuck at the middle part of the microcatheter and could not be inserted again.The physician attempted to remove it from the patient, but the outer sheath could not zip, so the microcatheter was flushed, and the deltafill18 (dlf181650/ lot s13274) was delivered to the target lesion.However, after several times of insertion and withdrawing, it was confirmed that the coil was unraveled in the microcatheter.Therefore, it was removed from the patient.The coil embolism was proceeded and completed.The physician commented that the assistant was not an experienced doctor.Also, the physician felt that the sheaths seemed to be weak.The procedure was successfully completed without further issues.There was also no patient injury / complication reported.The patient¿s vessel was mildly torturous.The patient¿s vessel level calcification was unknown.The complaint product was new and stored per labeling instructions and were used and prepped per the ifu.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to or after the event.No unintended detachment was observed in the vessel or in the microcatheter.The products are not available for the investigation.No further information is available.

• Brand Name: DELTAFILL18
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 7033072
• MDR Text Key: 93086954
• Report Number: 3013875781-2017-00028
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077145
• UDI-Public: (01)10886704077145(17)200131(10)S13274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: DLF181650
• Device Lot Number: S13274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1